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The Great RIF(T): One FDA Division’s Destruction and What it Could Mean for Generic Drugs

The FDA Law Blog

Indeed, since 2014, DPD facilitatedthe publication of 42 quarterly batches and dozens of stand-alone PSGs, plus three one-off batches of PSGs updated to align with recommendations in general guidance documents ( g. , Publishing virtually every GDUFA guidance and MAPP since 2014 to fulfill FDAs GDUFA commitments. 314.150(c).

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New biosimilar pathways – key takeaways from the EMA’s draft reflection paper

European Pharmaceutical Review

Document 9286/25. The European Medicines Agency (EMA) has published a draft reflection paper that signals a potential evolution in the regulatory landscape for biosimilar development within the EU. Guideline On Similar Biological Medicinal Products, CHMP/437/04 Rev 1. European Medicines Agency. Guillen E, Ekman N, Barry S, et al.

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ICH Q6B for Analytics

PharmTech

While the document itself is a quarter of a century old at this point, it is laid out in such a way that relevancy is maintained. This guideline forms the key document referenced by regulatory authority documents that detail structural characterization requirements of biopharmaceuticals. Analytical Validation (ICH, 2023).

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Insurance stopped covering my GLP-1: What to do next

The Checkup by Singlecare

A study by Xcenda found that only about 40 diabetes, weight loss, endocrine, and metabolic drugs had been excluded from at least one pharmacy benefit manager (PBM) formulary in 2014. Insurance companies may make exceptions on a case-by-case basis, but they’ll need to review some documentation from your healthcare provider. “The

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Pharmaceutical Compounding Calculations, Part Two–Bulk Drugs

PharmTech

It builds on drug calculations topics previously described (1), including guidance documents (2–5). FDA guidance documents illustrate labeling salt drugs and associated active moieties. FDA, USP Salt Policy (December 2014). 1, 2014 (accessed April 29, 2025). YouTube.com , Dec.

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The unsustainability of clinical trials and need for transformative change

Pharmaceutical Technology

According to a November 2024 GlobalData report, per-trial costs have risen steadily since 2014, with single country trials increasing by 2.9% To learn more about the solutions provided by Paradigm Health, download the document below. per year and multinational studies rising by 4.9% per year over this decade.

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Better Late Than Never: FDA Published FR Notices For De Novo Classifications Dating As Far Back as 2013

The FDA Law Blog

This editorial change began in December 2019 to indicate that the document amends the Code of Federal Regulations. By Véronique Li, Senior Medical Device Regulation Expert — In late June, FDA published five Federal Register notices that caught our eye, particularly for the dates the classifications were first applicable.

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